FDA.report

MediDent

Primary DI
16971911299009
Brand
MediDent
Company
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Model
01
Device description
Safety Needle 25G*1"
Published
2021-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16971911299009PackageGS1100In Commercial Distribution
26971911299006PackageGS11600In Commercial Distribution
06971911299002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697191129900916971911299009
2697191129900626971911299006
06971911299002069719112990026971911299002

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
554400604
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
16971911290723micsafe 12023-05-31
16971911290730micsafe 12023-05-31
16971911290747micsafe 12023-05-31
16971911290754micsafe 12023-05-31
16971911290761micsafe 12023-05-31
16971911290778micsafe 12023-05-31
16971911291072micsafe 12023-05-31
16971911291089micsafe 12023-05-31
06971911291099BIAL12023-05-31
06971911291105BIAL12023-05-31
06971911291112BIAL12023-05-31
06971911291129BIAL12023-05-31
06971911291143BIAL12023-05-31
06971911291150BIAL12023-05-31
06971911291167BIAL12023-05-31
16971911291171micsafe 12023-05-31
16971911291188micsafe 12023-05-31
16971911291195micsafe 12023-05-31
16971911291508micsafe 12023-05-31
16971911291515micsafe 12023-05-31

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